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Low recruitment
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Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis
This study will evaluate 24 patients with calcified NCC and edema in three treatment arms to compare the reduction in edema volume
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Active Comparator | 750 mg acetazolamide p.o. divided in three dily doses, for 10 days |
|
| Dexamethasone | Active Comparator | 8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering |
|
| No additional anti-edema treatment | No Intervention | No additional treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | As described above |
| |
| Dexamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Volume of Perilesional Edema Between Baseline and Day 4 | MRI extension of edema | Baseline to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Volume of Perilesional Edema Between Baseline and Day 8 | MRI extension of edema | Baseline to Day 8 |
| Decrease in Volume of Perilesional Edema Between Baseline and Day 30 | MRI extension of edema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hector H. Garcia, MD, PhD | Universidad Peruana Cayetano Heredia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas | Lima | Lima 1 | Peru |
As a concrete product, the clinical trial should provide base data to implement an affordable therapy for edema-related seizures. The data produced was going to be published in a peer reviewed journal; nevertheless, the study was prematurely terminated due to low recruitment.
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| ID | Term |
|---|---|
| D020019 | Neurocysticercosis |
| ID | Term |
|---|---|
| D020809 | Central Nervous System Helminthiasis |
| D020807 | Central Nervous System Parasitic Infections |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
As described above |
|
| Baseline to Day 30 |
| D010272 | Parasitic Diseases |
| D003551 | Cysticercosis |
| D013622 | Taeniasis |
| D002590 | Cestode Infections |
| D006373 | Helminthiasis |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |